According to Gavi, vaccine development takes 10-15 years on average. Experts attribute much of this time to clinical trials.
Contract research organizations (CROs) and trial sponsors usually deal with the cost and time burdens of these lengthy processes.
But why does the process take this long when there are innovative therapies that could help patients health-wise and help pharmaceutical and medical companies economically?
One of the most prevalent answers to this question is the complexity of the process, which typically includes massive amounts of data and multiple layers of involvement from stakeholders and decision-makers.
The complexity of clinical trials
Complex life science processes require extensive collaboration across a broad, growing and often global ecosystem. Taking a therapy from inception to reality involves many teams of people, working in a variety of disciplines, across multiple organizations, collaborating together in pursuit of a common goal — bringing innovative therapies to patients, faster.
The extensive data that must flow between stakeholders, participants, and decisionmakers. Unfortunately, the lack of transparency in the data flow often inhibits the speed of decision making, which lengthens the duration of clinical trials, results in unnecessary expenditures, and delays the ultimate delivery of therapeutics to patients.
Factors contributing to this complexity
Here is a look at three of the most prevalent factors contributing to intricate ecosystems within clinical trials.
The move toward decentralized clinical trials, with a greater number of investigator sites with potentially less experience and infrastructure, calls for more process management to ensure data is collected and flows without affecting quality and timelines. Consistent decision-making and proper oversight are all central to achieve reproducible results.
Compliance with several rules and regulations
The General Data Protection Regulation (GDPR) and the U.S. Food and Drug Administration’s 21 CFR Part 11 are only two of the regulations that clinical trial stakeholders must navigate. To prevent costly delays, fines, or even outright rejection, clinical trial stakeholders need significant resources and effort to ensure compliance.
Coordinating multiple sites and stakeholders
Managing multi-year clinical trials is challenging, with multiple stakeholders and participants including; sponsors, CROs, study investigator sites and other partners, who need to effectively collaborate to provide quality data throughout the clinical trial process.
Judi puts the flow back into workflow
A collaboration platform like Judi is the optimum solution to alleviate these and other clinical trial pain points. Judi empowers and enhances the world’s clinical trial ecosystems. Our cloud collaboration platform enables complex end-to-end process management and collaboration, supporting your unique workflows.
These are the core principles of Judi:
- Client Centricity: We offer a range of focused, innovative solutions designed to deliver your desired business outcomes, while adapting to your workflows.
- Orchestrated Collaboration: We know integration is critical, so we seamlessly connect teams, sites and partners across the journey, enabling extensive collaboration.
- Robust Simplicity: We recognize and reduce complexity to enable a more seamless, transparent and tailored experience.
- Efficiency & Security: We use purposeful automation with leading security to ensure optimized process management and deeper insights.
Contact us to learn more about how Judi can help automate, expedite and improve outcomes in your clinical trial.